Look up an FDA novel drug approval and find its approval package.
The FDA publishes an "Approval Package" for each newly approved drug — the medical review, statistical review, pharmacology review, chemistry review, label, and other documents that describe the basis for the agency's decision. Those documents are public and on accessdata.fda.gov, but the path from "drug name" to "the approval package" is several clicks of guesswork through FDA's site.
trove indexes FDA's novel drug approvals for 2021–2024 from both regulatory centers: CDER's annual NME/BLA lists and CBER's Approved Cellular and Gene Therapy Products page. Search for a drug, see its application number and approval date, and click straight through to the FDA's full approval-package overview where every PDF lives. This is a reference index, not a clinical resource. The approval package itself is the source of truth.
New to FDA approvals? Read what is an FDA novel drug approval for a plain-language explainer of NMEs, novel BLAs, and what's in an approval package.
Type a drug name above. The tool covers 218 novel drug approvals from 2021–2024 (CDER + CBER).
FDA publishes a curated list each year called Novel Drug Approvals — first-time approvals of meaningful new drugs (mostly NMEs and a handful of novel BLAs). That curated list, not every FDA approval, is what trove indexes. It's the set most public discourse cares about; routine approvals (label changes, generics, supplemental indications) aren't included.
Gives you: drug name, active ingredient, sponsor, approval date, indication summary, application number (NDA/BLA), and a deep link to the drugs@FDA application overview where every approval-package document lives. About two-thirds of rows also have a direct link to the FDA-approved label PDF (when FDA's annual page links to one); the rest link directly to the drugs@FDA overview.
Doesn't give you: pre-extracted content from the medical / statistical / pharmacology / chemistry reviews — those are large, varied PDFs and pre-extracting them is a separate project. The companion Claude skill fda-analyst reads those PDFs at query time when a user asks about a specific approval.
Doesn't cover: 2020 and earlier approvals (FDA archived the 2020 page; older years would need OCR), device approvals, generic approvals (ANDAs), and supplemental approvals (additional indications for already-approved drugs).
Two FDA centers, one combined index. CDER (Center for Drug Evaluation and Research) reviews small-molecule drugs and most antibody biologics; their curated Novel Drug Approvals page is the main feed. CBER (Center for Biologics Evaluation and Research) reviews cell and gene therapies; they appear on a separate FDA page. As of v0.2, trove ingests both. Each row carries a regulatory_center column. Lenmeldy, Casgevy, Lyfgenia, Beqvez, Hemgenix, Roctavian, and other recent gene therapies are now included.
The fda-analyst Claude Code skill answers natural-language questions about a specific approval by fetching the relevant PDFs from FDA and reading them at query time.
/plugin marketplace add cbetz/trove
/plugin install trove@troveThen ask things like: